Generate Life Sciences (Generate) today announced the establishment of its Good Manufacturing Practice (GMP) facility in La Jolla, California which will enable end-to-end manufacturing for newborn stem cell biologics.
This facility will represent a big step in the evolution of Generate and its broader life sciences platform — adding the role of a personalized therapeutics developer with in-house manufacturing capabilities to its core international donor gamete, genetics service and newborn stem cell preservation business.
Newborn stem cells, which include mesenchymal stem cells (MSCs), can be isolated from the tissue of the umbilical cord, and have a superior expansion capability compared to their adult-sourced counterparts. The new Generate facility has been designed to harness these inherent properties to maximize bioprocessing efficiency and manufacture at scale. It will be equipped with a bioreactor system, incorporate automation of key elements of the process and meet current GMP (cGMP) regulations — which ensures any biological products developed at the facility will meet the most up-to-date quality standards of the Food and Drug Administration (FDA).
“The La Jolla GMP facility will be a crucial addition to Generate’s vision for our newborn stem cell operation,” said Jaime Shamonki, MD, Generate’s Chief Medical Officer. “As the largest private newborn stem cell biorepository in the world, we believe it is our duty to continually invest in new scientific applications for newborn stem cells with the goal to increase access to novel therapies for families. With this facility, we will have the in-house capability to take these stem cells through the complete process of collection, cryogenic storage and ultimately biologics manufacturing. This will allow us to power our studies in a much more efficient and streamlined manner and help us better serve the families who have stored over 1.2 million stem cell units with us.”
MSCs can be efficiently isolated from the umbilical cord tissue and have numerous emerging clinical uses in regenerative medicine, given their potent anti-inflammatory, immune-modulating, and tissue reparative properties. MSCs are being utilized in an increasing number of clinical trials for cell therapy, gene therapy, tissue-engineering, and combination products. The clinical investigational cellular therapies derived from umbilical cord MSCs are targeting conditions such as autoimmune disease, acquired neurological diseases, lung disease, and conditions related to infertility.
Generate has achieved a history of firsts in the private newborn stem cell banking industry — the first US bank to store umbilical cord tissue to preserve MSCs, the first US bank to isolate clinically viable MSCs from cryopreserved composite umbilical cord tissue segments, the first to develop a method to assess umbilical cord tissue quality from composite tissue prior to freezing (ActivCord™), and the first private bank to have its isolated MSCs FDA approved for Investigational New Drug use in a scientific partner’s clinical trial, a validation of its prior foundational work. This facility lays the groundwork for Generate to continue this legacy and to help move the science of regenerative medicine forward.